Distalmotion announced it has received FDA 510(k) clearance for the use of its DEXTER Robotic Surgery System in adult cholecystectomy (gallbladder removal), representing the second approved indication in the United States following De Novo clearance for inguinal hernia repair in Q4 2024.
Significant Market Opportunity in Outpatient Surgery
Cholecystectomy represents a substantial clinical opportunity as one of the most frequently performed general surgeries in the United States. According to Greg Roche, CEO of Distalmotion, approximately one million cholecystectomy cases are performed annually, with 60 percent conducted in outpatient settings including hospital outpatient departments and ambulatory surgery centers (ASCs).
"With indications for inguinal hernia repair and now cholecystectomy, we're meaningfully building the reach of DEXTER in the US so that more surgical teams and patients will benefit from robotic surgery," Roche stated. "Our mission remains focused on empowering access to robotics with the right robot for the right site of care."
Purpose-Built Design for Outpatient Settings
The DEXTER system addresses the growing demand for robotic solutions in outpatient environments as more soft tissue procedures migrate to these settings. The system is specifically designed to deliver enhanced dexterity, precision, and surgeon ergonomics without compromising flexibility, efficiency, or cost considerations critical to outpatient operations.
Key features of the DEXTER system include a small, mobile footprint that integrates seamlessly into existing workflows to simplify operations and support high-volume procedures. The system's design allows it to fit into any size operating room without modifications and can be easily maneuvered between rooms to optimize efficiency.
Clinical Experience and Expanding Applications
Building on its growing footprint in the US and Europe, DEXTER has been utilized in 2,000 procedures across more than thirty procedure types spanning general, gynecological, colorectal, and urological surgery. This broad clinical experience demonstrates the system's versatility across multiple surgical specialties.
The sterile console supports flexible surgical workflows by positioning the surgeon close to the patient for quick bedside access, enabling seamless transitions between laparoscopic and robotic techniques as desired, and enhancing communication with operating room teams.
Ongoing Clinical Development
Distalmotion continues to expand access to robotic surgery in the US through its clinical development program. The company has completed its pivotal HYPER study (NCT06473675) for benign hysterectomy and maintains ongoing patient enrollment in its sacrocolpopexy clinical trial, indicating potential future indications for the DEXTER system.
The DEXTER Robotic Surgery System features fully wristed single-use robotic instruments that enhance dexterity and precision, while its open architecture enables compatibility with existing and future operating room technologies, including visualization systems and advanced devices, supporting cost-effective supply chain operations.
The system's instinctive design ensures an efficient learning curve for both setup and use, addressing a key consideration for adoption in busy outpatient surgical environments. Currently, the DEXTER Robotic Surgery System is authorized for use in adult inguinal hernia repair and cholecystectomy in the United States, with broader indications available in European markets for urologic, general, and gynecologic laparoscopic surgical procedures.
